ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ DESIGN OF THIS CASE REPORT FORM (CRF) There are two sets of Case Report Forms (CRFs) to be used in combination - Neonate and Maternal. The CRFs are to be used in combination for prospective cohort studies or case control studies. These sets of CRFs are to be use at admission and at discharge/going home. For any patients admitted for more than 24 hours, the Baseline and Outcome CRF and the Laboratory Results CRF can be copied and used for daily data recording. For all studies, we recommend completing a minimum of the (1) Neonate Baseline and Outcome CRF and (2) Neonate Laboratory Results CRFs for all Neonates post – delivery. If the neonate is admitted to an Intensive Care Unit or Paediatric Intensive Care Unit, complete (3) Neonate Intensive Care as well. For all studies complete the (4) Maternal Baseline and Outcome, (5) Maternal Laboratory Results, and (6) Maternal Antenatal Care CRFs as well. For pregnant women presenting with acute symptoms, complete (7) Maternal Acute Symptoms, and (8) Maternal Intensive Care only if the patient is admitted to Intensive Care Unit. Complete the outcomes sections in CRFs (1) and (4) once all diagnostics laboratory results and final diagnosis are available. HOW TO USE THIS CRF When completing the CRF modules, please make sure that: The mother or consultee/guardian/representative has been given information about the observational study and the informed consent form has been completed and signed. The study ID codes will be assigned for both mother / pregnant woman and neonate as per hospital protocol and guidelines. The study ID codes should be filled in on all pages of paper CRF forms, all information should be kept confidential at all times, and no patient identifiable information is recorded on the CRFs. Patients’ hospital ID and contact details should be recorded on a separate contact list to allow later follow up. The contact forms must be kept separate from the CRFs at all times and keep in a secure location. Each site may choose the amount of data to collect based on available resources and the number of patients enrolled to date. Ideally, data on patients (neonate and mother) will be collected using all CRF modules as appropriate. Sites with very low resources or very high patient numbers may select NEONATE/MATERNAL BASELINE AND OUTCOME CRF modules only. The decision is up to the site Investigators and may be changed throughout the data collection period. All high quality data is valuable for analysis. GENERAL GUIDANCE The CRF is designed to collect data obtained through patient examination, for neonate through parent/guardian/representative interview and review of hospital notes. Patient ID codes should be filled in on all pages of paper CRF forms (neonate and mother). Complete every line of every section, except for where the instructions say to skip a section based on certain responses. Selections with square boxes (☐) are single selection answers (choose one answer only). Selections with circles ( ○) are multiple selection answers (choose as many answers as are applicable). It is important to know when the answer to a particular question is not known. Please mark the ‘Unknown’ box if this is the case. Some sections have open areas where you can write additional information. To permit standardised data entry, please avoid writing additional information outside of these areas. We recommend writing clearly in black or blue ink, using BLOCK-CAPITAL LETTERS. Place an (X) when you choose the corresponding answer. To make corrections, strike through (----) the data you wish to delete and write the correct data above it. Please initial and date all corrections. Please keep all of the sheets for a single woman and neonate included in the study together e.g. with a staple or in a folder that is unique to the patient. Please contact us at info@isaric.org if we can help with CRF completion questions, if you have comments and to let us know that you are using the forms. ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 1 ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ 1) LABORATORY RESULTS (record all values available as part of standard care within 24 hours of presentation/admission) Complete all values available as part of routine care. Mark the correct unit where indicated. Use the most abnormal value per day. If Not Available, enter ND = not done, or if Unknown = UK. Test Hemoglobin Hematocrit White blood cell count Neutrophils (absolute count) Lymphocytes Monocytes Eosinophils Basophils Erythrocyte sedimentation rate C-reactive protein Platelets APTT PT (seconds) Urea Albumin Potassium Creatinine Glucose Amylase Bilirubin AST/SGOT ALT/SGPT ALP GGT Creatine kinase Other biochemistry result (specify): Other biochemistry result (specify): ND or UK Value Specify unit Date of sampling (dd/mm/yyyy) ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 2 ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ 2) CSF SAMPLE (if available as part of routine care) Date of lumbar puncture (dd/mm/yyyy):___ / ____ / 2 0 __ Test Please record value below Specify unit used CSF glucose ☐mmol/l Plasma glucose at time of LP* ☐mmol/l CSF WBC count ☐per mm3 CSF RBC count: ☐per mm3 Lymphocytes ☐% Neutrophils ☐% CSF protein ☐mg/dl If other unit used, specify unit here Other (specify): *Must be taken within 4 hours of the lumbar puncture, record capillary blood glucose if laboratory glucose not done CSF APPEARANCES CSF appearance ☐Clear and colourless ☐Cloudy ☐Blood stained ☐Unknown Gram stain ☐Negative ☐Positive ☐Not done CSF PATHOGENS DETECTED Pathogen Method Result PCR Culture Serology ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative PCR Culture Serology PCR Culture Serology PCR Culture Serology Test used ☐Positive ☐Negative ☐Positive ☐Negative ☐Positive ☐Negative ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 3 ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ 3) PLACENTA PATHOLOGY (if post-delivery) Placenta sent for pathology If yes, please specify results: ☐Yes ☐No ☐Unknown 4) REGIONAL REFERENCE LABORATORY RESULTS Please record details of any samples analysed in the regional reference laboratory. Name of regional reference Lab.:____________________________________________ City/town: ______________________________________________________________ Sample type (e.g. blood) Date of sampling Test method Pathogen detected and results (dd/mm/yyyy) __ / ___ / 20 __ __ / ___ / 20 __ __ / ___ / 20 __ __ / ___ / 20 __ ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 4 ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ 5a) PATHOGEN TESTING – ARBOVIRUSES Please record all pathogen testing carried out for diagnosis and differential diagnosis. Please record all results available from local, regional and/or regional reference laboratory. If the pathogen has not been tested, or it is not known, please record ND for Not Done, or UK for Unknown. Pathogen ND, UK Sample type Zika virus Zika virus Zika virus Zika virus Dengue virus Dengue virus West Nile virus West Nile virus Chikungunya virus Chikungunya virus Other (specify): (e.g. blood, urine, saliva) Date of sampling Test method Results Comments Serology Test used: Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative (dd/mm/yyyy) PCR Culture Other test (specify): Serology Test used: PCR Culture Other (specify): Serology Test used: PCR Culture Other test (specify): Serology Test used: PCR Culture Other test (specify): Serology Test used: PCR Culture Other test (specify): Serology Test used: ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 5 ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ Other (specify): PCR Culture Other test (specify): Positive Negative Unclear 5b) PATHOGEN TESTING - OTHER INFECTIONS Pathogen ND, Sample type UK (e.g. blood, urine, saliva) Date of sampling Test method Results Comments Malaria Serology Test used: Malaria Syphilis PCR Culture Other test (specify): Serology Test used: Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Syphilis Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Cytomegalovirus Cytomegalovirus Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Toxoplasma Toxoplasma Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Rubella Rubella Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear (dd/mm/yyyy) PCR Culture Other test (specify): Serology Test used: PCR Culture Other test (specify): Serology Test used: PCR Culture Other test (specify): Serology Test used: PCR Culture and sensitivity Other test (specify): ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 6 ZIKA VIRUS CASE REPORT FORM – MATERNAL LABORATORY RESULTS Birth mother’s identification code: _________________Neonate ID code: ________________________ Herpes simplex virus Serology Test used: Herpes simplex virus Parvovirus B19 PCR Culture Other test (specify): Serology Test used: Parvovirus B19 Other (specify): PCR Culture Other test (specify): Serology Test used: Other (specify): PCR Culture and sensitivity Other test (specify): Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear Ig G positive Ig G negative Ig M positive Ig M negative Positive Negative Unclear 7) CASE REPORT FORM COMPLETED BY Name and role Signature ZIKV CRF Maternal Laboratory Results v1.0 28JAN2016 Date (dd/mm/yyyy) 7